The Effect and Safety of the Seasonal Trivalent Influenza Vaccine in Chronic Kidney Disease Patients Not on Dialysis

NCT ID: NCT02105519

Last Updated: 2014-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-06-30

Brief Summary

In recent years, several studies revealed that the current influenza vaccine strategy might be of minimal vaccine effectiveness and had a smaller effect on reducing morbidity and mortality in the end-stage renal disease population than previously thought. Thus, this also raised the question about the effectiveness of administration of influenza vaccination in chronic kidney disease patients not on dialysis. In this study, the investigators aim to evaluate the effectiveness of seasonal trivalent influenza vaccine, formulation 2013-2014, in patients with different stage of chronic kidney disease (CKD) not on dialysis.

Detailed Description

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by the method of hemagglutination inhibition (HI) and ELISA-based microneutralization (microNT-ELISA) assays. All participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 4). The investigators will collect serum of participants at the 5th weeks, 9th weeks, and 21th week post vaccination and evaluate the difference of immune response in these 3 groups.

Conditions

Immunogenicity and Adverse Drug Effect of Vaccines Influenza; Chronic Kidney Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The group receiving no influenza vaccine

Participants in this group will not receive any influenza vaccine (negative control group).

Group Type: NO_INTERVENTION

No interventions assigned to this group

One dose of AdimFlu-S group

Participants in this group will receive one dose of the seasonal trivalent influenza vaccine (one dose of AdimFlu-S group), formulation 2013-2014, at the initiation of the study. Each administered dose contain 15 ug virus antigen for each virus strain.

Group Type: EXPERIMENTAL

Seasonal influenza vaccine (AdimFlu-S)

Intervention Type: BIOLOGICAL

Participants receiving 0, 1 and 2 dose of AdimFlu-S during the study period.(a) No vaccination: no any influenza vaccination during the study period.(b) One dose of AdimFlu-S group: patient will receive one dose of Seasonal influenza vaccine (AdimFlu-S) at the initiation of the study.(c)Two doses of AdimFlu-S group: patients will receive one dose of Seasonal influenza vaccine (AdimFlu-S) at week 0 and 4 weeks after the initiation of the study.

Two dose of AdimFlu-S group

Participants in this group (Two dose of AdimFlu-S group)will receive the seasonal trivalent influenza vaccine, formulation 2013-2014, at the week 0 and 4 weeks after the initiation of the study. Each administered dose contain 15 ug virus antigen for each virus strain.

Group Type: EXPERIMENTAL

Seasonal influenza vaccine (AdimFlu-S)

Intervention Type: BIOLOGICAL

Participants receiving 0, 1 and 2 dose of AdimFlu-S during the study period.(a) No vaccination: no any influenza vaccination during the study period.(b) One dose of AdimFlu-S group: patient will receive one dose of Seasonal influenza vaccine (AdimFlu-S) at the initiation of the study.(c)Two doses of AdimFlu-S group: patients will receive one dose of Seasonal influenza vaccine (AdimFlu-S) at week 0 and 4 weeks after the initiation of the study.

Interventions

Seasonal influenza vaccine (AdimFlu-S)

Participants receiving 0, 1 and 2 dose of AdimFlu-S during the study period.(a) No vaccination: no any influenza vaccination during the study period.(b) One dose of AdimFlu-S group: patient will receive one dose of Seasonal influenza vaccine (AdimFlu-S) at the initiation of the study.(c)Two doses of AdimFlu-S group: patients will receive one dose of Seasonal influenza vaccine (AdimFlu-S) at week 0 and 4 weeks after the initiation of the study.

Intervention Type: BIOLOGICAL

Other Intervention Names

AdimFlu-S, manufactured by Adimmune company.

Eligibility Criteria

Inclusion Criteria

1. .Males and non-pregnant females and aged ≥ 18 years with chronic kidney disease not on dialysis;

2. .Willing and able to adhere to visit schedules and all study requirements;

3. .Subjects read and signed the study-specific informed consent.

4. .Subjects who has either received the first dose of 2013-2014 seasonal influenza vaccination before or not.

Exclusion Criteria

1. .Subject or his/her family is employed by the participated hospital;

2. .History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;

3. .Personal or family history of Guillain-Barré Syndrome;

4. .An acute febrile illness within 1 week prior to vaccination;

5. .Current upper respiratory illness, including the common cold or nasal congestion within 72 hours;

6. .Subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;

7. .Female subjects who are pregnant during the study.

8. .Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;

9. .Immunodeficiency, or under immunosuppressive treatment.

10. .Receipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples);

11. .Receipt of any blood products, including immunoglobulin in the prior 3 months;

12. .Any severe illness needed to be hospitalization within three months.

13. .Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yu-Tzu Chang

Attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming-Cheng Wang, MD

Role: PRINCIPAL_INVESTIGATOR

National Cheng Kung University and Hospital

Chin-Chung Tseng, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cheng-Kung University Hospital

Junne-Ming Sung, MD

Role: PRINCIPAL_INVESTIGATOR

National Cheng Kung University and Hospital

An-Bang Wu, MD

Role: PRINCIPAL_INVESTIGATOR

National Cheng-Kung University Hospital

Wei-Hung Lin, ＭＤ

Role: PRINCIPAL_INVESTIGATOR

National Cheng-Kung University Hospital

Locations

National Cheng Kung University

Tainan City, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yu-Tzu Chang, MD, MSc

Role: CONTACT

kangxiemperor@gmail.com

886-2353535 ext. 4930

Other Identifiers

A-BR-101-139

Identifier Type: -

Identifier Source: org_study_id